A Phase 2 interventional study of Gemcitabine (1000 mg/m^2) and Paclitaxel 80 mg/m2 weekly in Triple Negative Breast Cancer and Metastatic Triple-negative Breast Cancer, sponsored by The University of The West Indies. Not yet recruiting at 3 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by The University of The West Indies · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in women of African ancestry than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are women of African ancestry, specifically from Jamaica, Barbados and Ghana, are 18 years or older, have had a biopsy that shows that they have triple negative breast cancer (TNBC), and are willing to take part.
The main questions the trial aims to answer are:
To answer these questions, half of participants will be treated with Gemcitabine while half is treated with Paclitaxel. Both drugs are given by injection and have already been approved for breast cancer treatment. Participants will:
This is a Phase II, randomized, open-label, multicenter clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for women of African ancestry with metastatic triple-negative breast cancer (TNBC).
Eligible participants will be randomized in a 1:1 ratio to one of two treatment arms, stratified by study site (5 major hospitals in Jamaica, Barbados and Ghana). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Participants assigned to the investigational arm will receive Gemcitabine administered on days 1 and 8 of a 21-day cycle. Participants assigned to the control arm will receive Paclitaxel administered weekly according to institutional standard practice.
Tumor assessments- via MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) as appropriate- will be conducted at regular intervals to evaluate disease status. Safety assessments (blood test panels) will occur throughout the study, and patient-reported outcomes will be collected using validated quality-of-life instruments.
Participants will be followed for progression, adverse events and survival outcomes for up to 12 months following treatment initiation. Data will be collected and managed using a secure, HIPAA-compliant electronic data capture system in compliance with HIPAA (Health Insurance Portability and Accountability Act). All analyses will be conducted using de-identified data.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 750 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →The University of The West Indies is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal
Drug: Gemcitabine (1000 mg/m^2)
Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal
Drug: Paclitaxel 80 mg/m2 weekly
Drug page: Gemcitabine
Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal
Drug page: Paclitaxel
Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal
Progression-Free Survival (PFS)
Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first.
Time frame: Up to 5 years
Overall Survival (OS)
Time from randomization to death from any cause
Time frame: Up to 5 years
Quality of Life Score on EORTC QLQ-C30
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Covers 5 functional scales (Physical, Role, Cognitive, Emotional and Social), 3 symptom scales (Fatigue, Pain and Nausea/Vomiting) and a global health status scale. All are scored from 0 to 100 with higher scores corresponding to higher functioning or better quality of life on the functional and global health scales, and higher scores indicating greater severity of symptoms on the symptom scales.
Time frame: Up to 5 years
Quality of Life Score on EORTC QLQ-BR23
Quality of life assessed using the EORTC Quality of Life Questionnaire breast cancer-specific module (QLQ-BR23). This includes 4 functional scales (Body Image, Future Perspective, Sexual Functioning and Sexual Enjoyment) 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms and Breast Symptoms). All scales are scored from 0 to 100, with a high score representing higher functioning/better quality of life on the functional scales and worse symptoms on the symptom scales.
Time frame: Up to 5 years
Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0
Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame: Up to 5 years
Plan to share: Yes — De-identified individual participant data will be made available after the conclusion of the study to researchers with approved proposals via email request. Data sharing will require a signed data use agreement and be determined on a case-by-case basis.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning after publication of primary results and available for at least 5 years.
Access criteria: Access will be provided to researchers with methodologically sound proposals, subject to approval by the study investigators and execution of a data use agreement.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gemcitabine
Triple Negative Breast Neoplasms →
The University of The West Indies